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CTRI Number  CTRI/2020/04/024464 [Registered on: 03/04/2020] Trial Registered Prospectively
Last Modified On: 09/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the use of atropine(0.01%)eye drops in halting progression of myopia 
Scientific Title of Study   A prospective randomized interventional open label study to compare the efficacy and safety of atropine 0.01% eye drops in controlling progression of myopia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  AIIMS JODHPUR 
Address  Room No. 51, Ground Floor, C-Block Department Of Ophthalomology, AIIMS Jodhpur, Basni Industrial Area, Phase-2 Pin Code-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  moryaak@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  AIIMS JODHPUR 
Address  Room No. 51, Ground Floor, C-Block Department Of Ophthalomology, AIIMS Jodhpur, Basni Industrial Area, Phase-2 Pin Code-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  moryaak@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Kumar Morya 
Designation  Associate Professor 
Affiliation  AIIMS JODHPUR 
Address  Room No. 51, Ground Floor, C-Block Department Of Ophthalomology, AIIMS Jodhpur, Basni Industrial Area, Phase-2 Pin Code-342005 Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9812403786  
Fax    
Email  moryaak@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
Dr. Arvind Kumar Morya Room no 424, Dept. of Ophthalmology, AIIMS Jodhpur, Ground Floor, C-block, Basni Industrial Area Phase-2 
 
Primary Sponsor  
Name  Dr Arvind Kumar Morya 
Address  Room No.52, Ground Floor , C-block, Dept. of Ophthalmology, AIIMS Jodhpur. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Morya  AIIMS Jodhpur  Room no -425, Dept. of Ophthalmology, AIIMS Jodhpur, Ground Floor, C-block, Basni Industrial Area Phase-2
Jodhpur
RAJASTHAN 		 9812403786

moryaak@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.01% Atropine eye drops  Group A patients will be prescribed atropine eye drops 0.01% along with correction of refractive error for 2 year 
Comparator Agent  0.5% Carboxy methyl cellulose  Group B will be given only correction of refractive error along with 0.5% Carboxy methyl cellulose for 2 years 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  1. All patients with age group 05 to 23 years.
2. Gender male and female
3. Best corrected visual acuity should be 6/6 (20/20; LogMAR 0.0) or better in both eyes
4. Spherical equivalent should be equal to or more than -0.25Diopter
5. Both spherical and or cylindrical refraction would be included. Refraction would be based on cycloplegic refraction and subjective acceptance
6. Patients/legal guardian should be willing to use the eye drops on regular compliant basis.
7. Patients/legal guardian should be able to understand and sign an informed consent.
 
 
ExclusionCriteria 
Details  1. History of ocular inflammation or trauma or treatment of refractive error (medical or surgical)
2. Any ocular comorbidity limiting visual assessment, visual improvement.
3. Any type of amblyopia in one or both eyes.
4. Patient lost to follow up within 1 year of the study or not compliant with the treatment advised
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary:
To compare the the efficacy and safety of atropine 0.01% eye drops in controlling progression of myopia.
Secondary :
To evaluate the systemic and ocular side effects of atropine eye drops 0.01% in myopic patients.


 		 Change in spherical equivalent at the end of 2 years.
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopia  To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopia at 2 year of therapy 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 1.Kothari, M. & Rathod, V. Efficacy of 1 % atropine eye drops in retarding progressive axial myopia in Indian eyes. 65, 1178–1181 (2017). 2. Chia, A., Lu, Q. & Tan, D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2 Myopia Control with Atropine 0 . 01 % Eyedrops. 391–399 (2015). doi:10.1016/j.ophtha.2015.07.004 3. Chia, A. et al. Atropine for the Treatment of Childhood Myopia : Safety and Efficacy of 0 . 5 %, 0 . 1 %, and 0 . 01 % Doses ( Atropine for the Treatment of Myopia 2 ). OPHTHA 119, 347–354 (2011). 4. Update, A. E. Article for CME Credit Interventions to Retard Myopia Progression in Children. 415–421 (2002). 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 The prevalence of myopia has increased worldwide in recent decades. Atropine eye drops can slow myopia progression by an average of - 0.54 dioptres (D)/year in Asian children and - 0.35 D/year in Caucasian children. It is an Open label case control prospective study which will be conducted at AIIMS ,JODHPUR ,RAJASTHAN with sample size of 125 eligible patients in each group to compare the efficacy and safety of atropine 0.01% eye drops in controlling myopic progression in children. Group A:  receiving atropine eye drops 0.01% OD along with subjective correction of refraction with spectacles or contact lenses in both eyes. Group B: receiving only subjective correction of refraction. All patients will undergo complete ophthalmic and systemic evaluation. A follow-up visit will be done after 3 months (+/-7 days), 6 months (+/-7 days), 1 year (+/-7 days), 18 months (+/-7 days) and 24 months (+/-7 days) of first visit. Primary Endpoints will be Change in spherical equivalent at the end of 2 years. Data pertaining to demographic details, clinical investigations, will be recorded in predesigned format and data will be  transferred to an Excel spreadsheet. In case of side effects , the same drug will be discontinued and treated with an alternative standard drug. 
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